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Report of the Eye Bank Association of America Medical Review Subcommittee on Adverse Reactions Reported From 2007 to 2014

Edelstein, Sean L. MD; DeMatteo, Jennifer MCM, CIC; Stoeger, Christopher G. MBA, CEBT; Macsai, Marian S. MD; Wang, Chi-Hsiung PhD

doi: 10.1097/ICO.0000000000000869
Clinical Science

Purpose: To investigate the incidence of adverse reactions after corneal transplantation, reported to the Eye Bank Association of America.

Methods: Incidence of adverse reactions from January 1, 2007, to December 31, 2014, was analyzed.

Results: Of the 354,930 transplants performed in the United States, adverse reactions were reported in 494 cases (0.139%). Primary graft failure (PGF) predominated (n = 319; 0.09%) followed by endophthalmitis (n = 99; 0.028%) and keratitis (n = 66; 0.019%). The procedure type predominantly associated with PGF was endothelial keratoplasty (EK) in 56% (n = 180; 11 per 10,000 grafts), followed by penetrating keratoplasty (PK) in 42% (n = 135; 6.9 per 10,000 grafts). The procedure type predominantly associated with endophthalmitis and keratitis was EK in 63% (n = 104; 6.3 per 10,000 grafts) followed by PK in 34% (n = 56; 2.8 per 10,000 grafts), anterior lamellar keratoplasty in 1% (n = 2; 2.7 per 10,000 grafts), and keratoprosthesis in 1% (n = 2; 12.4 per 10,000 grafts). Although the incidence of PGF and endophthalmitis between PK and EK was noteworthy, the difference was not statistically significant (P = 0.098). Endophthalmitis-associated pathogens were isolated in 78% of cases: predominantly Candida species (65%), gram-positive organisms (33%), and gram-negative rods (2%). Keratitis-associated pathogens were isolated in 64% of cases: predominantly Candida species (81%), Herpes simplex virus (7%), gram-negative organisms (7%), and gram-positive organisms (5%).

Conclusions: PGF was the most commonly reported adverse reaction, disproportionately associated with EK. An increasingtrend in the rate of endophthalmitis and keratitis was observed, disproportionately associated with EK and Candida species.

*Department of Ophthalmology, Saint Louis University School of Medicine, Saint Louis, MO;

Eye Bank Association of America, Washington, DC;

Lions VisionGift, Portland, OR;

§Division of Ophthalmologyl; and

Center for Biomedical Research Informatics, NorthShore University HealthSystem, Division of Ophthalmology, Evanston, IL.

Reprints: Sean L. Edelstein, MD, 1755 S. Grand Boulevard, St. Louis, MO 63104 (e-mail: edelstein@doctor.com).

The authors have no funding or conflicts of interest to disclose.

Received January 03, 2016

Received in revised form March 13, 2016

Accepted March 14, 2016

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